Full Text HS-96-002 MEDTEP RESEARCH ON NON-CANCEROUS UTERINE CONDITIONS NIH GUIDE, Volume 25, Number 6, March 1, 1996 RFA: HS-96-002 P.T. 34, II Keywords: Urogenital System Clinical Trial Agency for Health Care Policy and Research Letter of Intent Receipt Date: May 1, 1996 Application Receipt Date: June 18, 1996 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications for cooperative agreements to design and conduct collaborative, multi-site randomized controlled trials to compare the effectiveness and outcomes of hysterectomy to those of other common treatments for non-cancerous uterine conditions. These trials will emphasize outcomes important to patients. The conditions of interest are: uterine fibroids (leiomyomata), endometriosis, dysfunctional uterine bleeding, and uterine prolapse. Each application must be submitted by the institution where the Data Coordinating Center is located. The Data Coordinating Center will be the applicant and control point for project coordination, and for management and analysis of the data. The project should include a consortium or network of Clinical Centers and a Study Chair. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), MEDTEP Research on Non-Cancerous Uterine Conditions, addresses several of those objectives. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, non-profit organizations, public and private, including universities, clinics, units of State and local governments, non-profit firms, and non-profit foundations. Racial/ethnic minorities, women, and persons with disabilities are encouraged to apply as Principal Investigator. MECHANISM OF SUPPORT The administrative and funding instrument will be the cooperative agreement (U01) in which substantial AHCPR scientific and programmatic involvement with the awardee is anticipated during the performance of the project. The total project period for each application submitted in response to this RFA may not exceed five years. The earliest anticipated award date is September 1, 1996. FUNDS AVAILABLE Dependent upon the availability of funds, AHCPR expects to award up to $3 million to support the first year of approximately three projects under this RFA. The number of awards is dependent on the number of high quality applications and their individual budget requirements; it is not the intent of AHCPR that the awards be equal in size. This is a one time solicitation. Funding beyond the initial budget period will depend upon annual progress reviews by AHCPR and the availability of funds. RESEARCH OBJECTIVES Background This RFA is part of AHCPR's Medical Treatment Effectiveness Program (MEDTEP), which is a major component of the health services research agenda of AHCPR. MEDTEP projects assess the relative effectiveness and costs of available interventions for the prevention, diagnosis, treatment, and management of disease, emphasizing a broad set of outcomes important to patients. MEDTEP projects are patient-centered and policy relevant; they focus on common clinical problems and attempt to determine which clinical services and procedures are most effective, and for whom. In all MEDTEP work, the generalizability of findings is emphasized. Non-Cancerous Uterine Conditions This RFA addresses the subject of non-cancerous uterine conditions, specifically uterine fibroids (leiomyomata), endometriosis, dysfunctional uterine bleeding, and uterine prolapse. In May 1994, AHCPR convened a public meeting to explore the important unanswered effectiveness questions regarding the proper role of hysterectomy and to examine research priorities in the management of non-cancerous uterine conditions. The meeting provided a forum for critical review and discussion of the scientific literature and identification of the important research questions in each of the clinical conditions listed above. There was a consensus of the meeting participants that the scientific literature related to non-cancerous uterine conditions provides little hard evidence of effectiveness for any of the available treatments, and that there is a critical need for studies that would compare the outcomes of hysterectomy to other available treatments. Prospective applicants are encouraged to obtain a copy of the summary of the May meeting, which includes recommendations for research and references (See INQUIRIES). The management of non-cancerous uterine conditions includes a variety of invasive and noninvasive treatments: surgical, pharmacologic, and other treatments. There has been little research demonstrating the effectiveness of these treatments relative to each other or compared to watchful waiting. Approximately 530,000 hysterectomies are performed annually for non-cancerous conditions, at a cost for hospitalization of over $5 billion (Wilcox, 1994). Most of these procedures are performed for one of several common, non-cancerous conditions that often produce pain, discomfort, excessive uterine bleeding, emotional distress, and related symptoms. National data for 1988-1990 reveal that most women who undergo hysterectomy are between the ages of 35 and 54, with the highest age-specific rate for women 35-44 (11.8 per 1,000). By the age of 65, over one third of U.S. women have undergone this surgery. Except for some preliminary studies funded by AHCPR (Carlson, 1993; Kjerulff, 1993; Kritz-Silverstein, 1994), few studies provide information about the effects of hysterectomy on the symptoms that lead to treatment or on the long-term outcomes that contribute to the patient's quality of life, functional status or satisfaction with the care received. Purpose and Scope of the Activity This RFA solicits studies that will directly compare the effectiveness of hysterectomy to other common treatments for non-cancerous uterine conditions. AHCPR intends to initiate up to four separate, collaborative, randomized controlled trials (RCTs) that will compare the outcomes of hysterectomy to those of other common treatments. AHCPR is also interested in cost analyses of effective treatments evaluated in the proposed trial. Applicants should pay special attention to defining the outcomes to be measured and should include outcomes that are of greatest concern to women seeking care for non-cancerous uterine conditions. Each application is to propose an RCT comparing hysterectomy with one or more other treatment(s), for one of the following conditions: o Uterine fibroids o Endometriosis o Dysfunctional uterine bleeding o Uterine prolapse Applicants may submit one or more applications, each proposing a different RCT. For each trial, the application must be submitted by the Principal Investigator of the Data Coordinating Center, who will have responsibility for project coordination and for the management and analysis of the data to be collected by the Clinical Centers. The Study Chair will participate in the development of the proposed study, and will provide clinical leadership to the Data Coordinating Center and the Clinical Centers throughout the study. The proposed Clinical Centers should be identified and should participate in the development of the proposed protocol, which is to be presented, in detail, in the application. The final protocol, sampling plan, and manual of operations will be developed jointly by the Steering Committee with the assistance of AHCPR, and will be reviewed by an independent expert group, called the Policy and Data Monitoring Committee. The study will move into its operational phase (Phase 2) only with the concurrence of the Policy and Data Monitoring Committee and AHCPR. It is expected that the trials supported under this RFA will be carried out over a period of five (5) years. Each trial will progress through the following phases: Phase 1: The planning phase includes the collaborative development/refinement of the protocol and manual of operations, including all procedures for data collection and pretesting of procedures. The manual of operations will include detailed plans for the training of all personnel in study procedures. If the final sampling plan requires additional or different Clinical Centers to meet patient enrollment targets, these will be recruited by the Data Coordinating Center in Phase 1. Phase 2: Conduct of the full-scale collaborative clinical trial, including patient recruitment and all data collection. Phase 3: Analysis of data and reporting of results. SPECIAL REQUIREMENTS One of the proposed Clinical Centers may be at the same institution as the Data Coordinating Center provided that the units are administratively and fiscally distinct. Study Organization 1. Study Outline. The proposed study design must include the rationale for the treatments addressed, detailed description/explanation of the approach to randomization, clinical variables and patient outcomes to be studied, and an estimate of the number of patients required in each study arm to provide convincing evidence that the results will be statistically and clinically significant. Applicants should provide a detailed justification for whatever strategy is proposed for subject selection, eligibility requirements, inclusion and exclusion criteria for enrollment, an estimate of the number of subjects in the source population, approach to randomization, and an estimate of the necessary time and effort needed for recruitment. The approach should allow for subanalyses, such as socioeconomic status. All Clinical Centers must agree to implement the protocol and manual of operations developed cooperatively by the Steering Committee (defined in section 2d below) during Phase 1, and agree to transmit all study data to the Data Coordinating Center for aggregation and analysis. 2. Study Components a. Data Coordinating Center. The institution where the Data Coordinating Center and the Principal Investigator are located will be the applicant. The Data Coordinating Center will have a major role in study design and primary responsibility for project coordination, and data management and analysis. The Principal Investigator will oversee all activities of the Data Coordinating Center and will have the responsibility for the overall management of the project budget and resource use. The Data Coordinating Center will maintain a stable core of expertise for the conduct of data management and analysis. It is desirable to also have health services research expertise in the core. The Principal Investigator will serve as the primary methodologic expert for the study. This individual should be an experienced biostatistician, epidemiologist, physician, or other professional with experience in directing a coordinating center for a large-scale collaborative clinical trial. The application should present a complete and detailed preliminary trial design, including specification of hypotheses to be tested, discussion of measures and instruments, rationale and inclusion criteria for subject selection, how surgical versus non-surgical patients will be managed and by whom, the plans for recruitment and follow-up of study participants, and a data analysis plan. The application should include a succinct discussion of previous relevant experience as a coordinating center for a collaborative trial or other large-scale epidemiological research projects, including the implementation of systems for communication and coordination among investigators and sites. Responsibilities of the Data Coordinating Center and the Principal Investigator include monitoring both the quality of the data and the performance of each Clinical Center in the conduct of the protocol, as well as ensuring the safety and confidentiality of all data. The applicant should discuss in detail the important management and resource considerations for coordination of the proposed trial. The Data Coordinating Center will perform interim analyses as needed to monitor the course of the trial as well as analyses needed for final reporting. Preparation of progress reports, final reports, and articles will be collaborative undertakings by the Principal Investigator of the Data Coordinating Center, the Study Chair, and the Clinical Centers. The Principal Investigator will participate with the Study Chair, the Clinical Centers, the Steering Committee, and AHCPR staff during the entire clinical trial. b. Study Chair. The Study Chair will provide clinical leadership and research direction to the Clinical Centers and the Steering Committee. This individual will work actively and collaboratively with the Principal Investigator regarding the clinical aspects of the protocol throughout the study. The application should include a succinct discussion of previous relevant experience of the Study Chair in a collaborative trial or other large scale epidemiological research project. c. Clinical Centers. The Clinical Centers will recruit and follow study participants. Each Clinical Center should consist of a core team of researchers, gynecologists, a Clinical Director, and a full-time Clinic/Nurse Coordinator. Each Clinical Director should be a gynecologist who will oversee the enrollment and follow-up of the patients in the particular Center and coordinate the activities of the medical team. A full-time Clinic/Nurse Coordinator should manage clinical aspects of the trial including logistical aspects of patient recruitment, follow-up, survey administration, and data transmittal to the Data Coordinating Center. The Clinical Director and treatment team in each Clinical Center should be skilled in the treatment of non-cancerous uterine conditions as well as in collaborative clinical investigation. In order to maximize the generalizability of the study results, efforts should be made to select Clinical Centers with patient populations that are adequate for important subanalyses, such as race and ethnicity, income, and age. Efforts should also be made to include Clinical Centers that provide a mix in terms of geography and academic versus non-academic affiliations. Clinical Centers will be required to submit all data expeditiously to the Data Coordinating Center for analysis. The application should describe the experience of each Clinical Center in recruiting, studying, and treating patients with non-cancerous uterine conditions, and the ability of each Center to minimize loss of patients to follow-up during long-term clinical studies. There should be evidence of strong institutional support for each Clinical Center, including documentation of adequate facilities for clinical and administrative project activity. An organizational structure for each Clinical Center should be provided in the application delineating lines of authority and responsibility. In addition, a statement of agreement to follow the common protocol developed in Phase 1, and to work cooperatively with the other Clinical Centers, the Study Chair, and the Data Coordinating Center should be included. d. Steering Committee. The Steering Committee will be the primary governing body. Managing the scientific direction of the study will be the responsibility of the Steering Committee and its chairman, i.e., the Study Chair. The Steering Committee will consist of the Principal Investigator from the Data Coordinating Center, the Clinical Directors of each Clinical Center, the Study Chair, and the AHCPR Project Coordinator (See Terms and Conditions). e. Policy and Data Monitoring Committee. An independent Policy and Data Monitoring Committee will be appointed by AHCPR. The purpose of this committee is to review periodically the progress of the study. The activities of this committee will not be the responsibility of the grantee (See Terms and Conditions). f. Project Coordinator. AHCPR will name a staff member from the Center for Outcomes and Effectiveness Research (COER) as the Project Coordinator. The functions of the Project Coordinator will be to work closely with the Steering Committee and the Policy and Data Monitoring Committee and provide technical assistance to assure that the study is carried out in a rigorous and efficient manner (described in detail under Terms and Conditions). Study Phases The protocol completed during the planning phase (Phase 1) will be reviewed by the Policy and Data Monitoring Committee and AHCPR. Progression to Phase 2 is dependent on the acceptance of the protocol by the Policy and Data Monitoring Committee and the concurrence of AHCPR. In Phase 2, the Clinical Centers will implement the protocol according to the manual of operations. This will include recruiting and randomizing patients, collecting all data specified in the protocol, and providing all data to the Data Coordinating Center for analysis. All patients must be followed for a minimum of two years. Phase 3 of the study will be for final data analysis, reporting of results, and close-out of project activities. Budget Preparation Applicants should submit adequately justified budgets for each year of the anticipated five year project period. Additionally, a separate detailed budget for each subcontract is required. The costs of clinical care provided to participants in this clinical trial will not be paid out of grant funds. Confidentiality of Data Information obtained in the course of this study that identifies an individual or entity must be treated as confidential in accordance with section 903(c) of the Public Health Service Act. Applicants must describe in the Human Subjects section of the application procedures for ensuring the confidentiality of identifying information. Terms and Conditions of Award 1. Cooperative Activities. The administrative and funding mechanism to be used for this program will be the cooperative agreement (U01) in which substantial AHCPR scientific and programmatic involvement with the awardee(s) is anticipated during the performance of the activity. Consistent with this concept, AHCPR will be involved substantially in the operations and research efforts by working collaboratively with the awardee in a partner role. 2. Awardee Responsibilities. These include development and refinement of the study protocol and operations manual, patient recruitment and follow-up, data collection, quality control, data analysis and interpretation, and preparation of publications. The awardee agrees to finalize the common protocol and develop the manual of operations during Phase 1 of the study. 3. AHCPR Responsibilities. AHCPR will name a Project Coordinator from within the Center for Outcomes and Effectiveness Research, who will work closely with the Steering Committee and Policy and Data Monitoring Committee throughout the project. In particular, the AHCPR Project Coordinator will assist in quality control, review of data analysis plans and interpretation, preparation of publications, and coordination and monitoring of project performance. The independent Policy and Data Monitoring Committee, supported by AHCPR, will consist of individuals with expertise in relevant medical, surgical, social science, health services research, and methodological fields who are not directly involved in the study. The function of this Committee will be to review periodically the progress of the study. Specifically, the Committee will oversee participant safety, evaluate results, monitor data quality, and provide operational and policy advice to the Steering Committee and AHCPR regarding the status of the study. Committee members will be appointed by the Director of COER in consultation with members of the Steering Committee. AHCPR will assume responsibility for logistics and costs associated with the activities of the Policy and Data Monitoring Committee. The AHCPR reserves the right to terminate or curtail the study (or individual components) in the event of (a) a major breach in the protocol or substantial changes in the agreed-upon protocol with which AHCPR does not agree, or (b) unresolved human subjects/ethical issues. 4. Governance. The primary governing body of the study will be the Steering Committee comprised of each of the Clinical Directors of the Clinical Centers, the Study Chair, the Principal Investigator of the Data Coordinating Center and the AHCPR Project Coordinator. The Steering Committee has primary responsibility for developing the common clinical protocol, facilitating the conduct and monitoring of the study, and reporting the study results. Each member of the Steering Committee will have one vote, except for the AHCPR Project Coordinator, who will be a non-voting member. The Study Chair will serve as the Chair of the Steering Committee. It is anticipated that the Steering Committee will meet on a monthly basis during protocol development (Phase 1), three times a year in Phase 2, and two times in Phase 3. Subcommittees of the Steering Committee may be established and will meet as necessary. The AHCPR Project Coordinator or designee and the Data Coordinating Center will be represented on each subcommittee. 5. Arbitration. Any disagreement that may arise in scientific and/or programmatic matters between awardees and AHCPR may be brought to arbitration. An arbitration panel will be composed of three members: one selected by the Steering Committee (without a vote by the AHCPR member), a second member selected by AHCPR, and a third member selected by the preceding two members. This special arbitration procedure in no way affects the awardees' right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR, Part 50, Subpart D, and DHHS regulations at 45 CFR, Part 16. The special terms of award described above are in addition to and not in lieu of otherwise applicable PHS grant policies and Federal regulations. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH STUDY POPULATIONS INVOLVING HUMAN SUBJECTS Since this RFA deals only with issues affecting women, the following applies to the inclusion of minorities in the study population. It is the policy of AHCPR that women and members of minority groups be included in all AHCPR supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. The NIH policy resulting from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) supersedes and strengthens NIH's previous policies (Concerning the Inclusion of women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which were in effect since 1990 and which AHCPR had adopted. The new NIH policy contains provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and printed in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 11, 1994, Volume 23, Number 10. AHCPR follows the revised NIH Guidelines, as applicable. Investigators may obtain copies from those sources or from the AHCPR contractor, Global Exchange, listed under INQUIRIES. AHCPR program staff may also provide information concerning this policy (See INQUIRIES). LETTER OF INTENT Prospective applicants are asked to submit, by May 1, 1996, a letter of intent that includes the name, address, and telephone number, of the proposed Principal Investigator and other key personnel; the identities of proposed consortia members, including any other participating organizations or institutions; a descriptive title of the proposed trial(s); and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the consideration of any subsequent application, the information allows AHCPR staff to estimate the potential review workload and avoid conflicts of interest in the review. AHCPR will not provide responses to letters of intent. Letters of intent are to be addressed to: Center for Outcomes and Effectiveness Research Attention: Ms. Joanne Book Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 605 Rockville, MD 20852-4908 Email: COER_RFA@PO4.AHCPR.GOV APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. State and local government applicants may use form PHS-5161-1, Application for Federal Assistance (rev. 9/92), and follow those requirements for copy submission. These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: girg@drgpo.drg.nih.gov. AHCPR applicants are encouraged to obtain application materials from the AHCPR contractor Global Exchange, Inc., 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3015; telephone 301/656-3100 or FAX 301/652-5264. The RFA label available in the form PHS 398 (rev. 5/95) must be affixed to the bottom of the face page of the original application. Failure to do so could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, in item 2 on the face page of the application, mark the "YES" box and enter "RFA HS-96-002" and the title. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Miriam A. Kelly, Ph.D. Center for Outcomes and Effectiveness Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 605 Rockville, MD 20852-4908 Applications submitted under this RFA must be received in the Division of Research Grants, NIH, by June 18, 1996. If an application is received after that date, it will be returned to the applicant without review. Seminar for Prospective Applicants AHCPR plans to convene a special technical assistance workshop to assist potential applicants, especially those with limited experience with the application process. The purpose of this seminar is to give background information and respond to any questions about the preparation of an application in response to this RFA. The workshop will be held in the Rockville/Bethesda, Maryland area approximately one month after the publication of this announcement. Attendance is not a prerequisite to applying. Attendees must pay for their own travel and accommodation costs. The workshop will be open to any individual or organization wishing to attend. A synthesis of pertinent Questions and Answers discussed at the prospective applicants meeting will be available from the AHCPR contractor, Global Exchange, Inc., listed under INQUIRIES. For further information contact Dr. Mim A. Kelly, at the mailing/internet address listed under INQUIRIES. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with AHCPR peer review procedures. As part of the merit review, all applications will receive a written critique, and also may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. Recommendations of the peer review committee may be reviewed subsequently by AHCPR's National Advisory Council. General Review Criteria Review criteria for AHCPR grant applications are: significance and originality from a scientific and technical viewpoint; adequacy of the method(s); availability of data or proposed plan to collect data required for the project; qualifications and experience of the Principal Investigator and proposed staff; adequacy of the plan for organizing and carrying out the project; reasonableness of the proposed budget; and adequacy of the facilities and resources available to the applicant (See also Special Review Criteria). Special Review Criteria In addition to the general criteria above, the reviewers will assess the application in terms of the SPECIAL REQUIREMENTS of this RFA, including: o adequacy of the proposed study design to address the objectives of the RFA, including criteria for subject selection, plans for recruitment of subjects, proposed follow-up assessments and schedule for data collection during follow-up, proposed diagnostic and therapeutic modalities, proposed outcomes measures, proposed cost analyses, and techniques for monitoring and maintaining continued contact with subjects during the course of the study; o ability to recruit and involve Clinical Centers that have the experience and capacity to select, treat, manage, retain, and follow a sufficient number of subjects for the study proposed; o clinical experience and research expertise of the Study Chair in the diagnosis, treatment and management of non-cancerous uterine conditions, and demonstrated leadership ability in the conduct of large clinical studies; o documentation of specific competence and previous experience of the professional, technical, and administrative staff pertinent to the operation of the Data Coordinating Center, working in collaboration with other investigators under a common protocol, and experience with careful and expeditious handling of study data; o prior experience in the collection, management, quality control, and analysis of data from multiple clinical sites; o prior experience in developing a detailed manual of operations and forms for multicentered clinical trials; o evidence of substantive institutional commitment and support for the proposed project; and o willingness to work cooperatively in the manner summarized above. AWARD CRITERIA Applications will compete for available funds with all other applications under this RFA. The following will be considered in making the funding decisions: quality of the proposed project as determined by peer review, program balance, and availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Copies of the RFA, the related background conference summary, and a bibliography are available from: Global Exchange Inc. 7910 Woodmont Avenue, Suite 400 Bethesda, MD 20814-3015 Telephone: (301) 656-3100 FAX: (301) 652-5264 Copies of the RFA and the background conference summary document (AHCPR Pub. No. 95-0067, July, 1995) can also be requested through e-mail at COER_RFA@PO4.AHCPR.GOV and through AHCPR InstantFAX at 301/594-2800. To use InstantFAX, you must call from a facsimile (FAX) machine with a telephone handset. Use the key pad on the receiver when responding to prompts from InstantFAX. The RFA will be sent at the end of the ordering process. AHCPR InstantFAX operates 24 hours a day, 7 days a week. For questions about this service, call AHCPR's Division of Communications at 301/594-1364 ext. 159. Direct inquiries regarding programmatic issues, including information on the policy of inclusion of women and minorities in study populations, to: Miriam A. Kelly, Ph.D. Center for Outcomes and Effectiveness Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 605 Rockville, MD 20852-4908 Telephone: (301) 594-1485 Email: COER_RFA@PO4.AHCPR.GOV Direct inquiries regarding fiscal matters to: Carol Roache Acting Chief, Grants Management Staff Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852-4908 FAX: (301) 594-3210 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.180. Awards are made under authorization of Title IX of the Public Health Service Act (42 U.S.C. 299-299c-6) and Section 1142 of the Social Security Act (42 U.S.C. 1320b-12). Awards are administered under the PHS Grants Policy Statement and Federal regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, The Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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